Catheter insertion apparatus

ABSTRACT

A catheter is provided including a first lumen and a second lumen. A first member is disposed for relative movement within the first lumen and defines a cavity, A second member is disposed for relative movement within the second lumen. The cavity of the first member is configured for disposal of the second member. The catheter may include an elongated tubular body that includes the first lumen and the second lumen. The first member may have a distal portion that extends beyond the distal end of the body. The distal portion may include the cavity. The cavity may be defined by a member lumen. The first and second members may include tubular stylettes. The second member may include a guidewire.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/880,012 filed Jan. 25, 2018, which is a continuation of U.S. patentapplication Ser. No. 11/266,319, filed on Nov. 4, 2005, now U.S. Pat.No. 9,913,962, which claims benefit of and priority to U.S. ProvisionalApplication No. 60/625,005, filed Nov. 4, 2004, the disclosure of eachof which is hereby incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION Technical Field of the Invention

The present disclosure relates generally to medical catheter apparatus,and more particularly to a catheter insertion apparatus.

Description of the Related Art

Catheters are known medical devices for administration of fluids withincavities, ducts, and vessels of a body. Various known catheter deviceshave been employed for simultaneous withdrawal and introduction of afluid within a body. These devices may utilize multiple lumens, such asdual lumen catheters that facilitate bi-directional fluid flow wherebyone lumen performs withdrawal of blood and the other lumen introducestreated blood to the vessel. In hemodialysis applications catheters areused to withdraw blood from a blood vessel and return the treated bloodback to the blood vessel after the blood is treated by an artificialkidney device.

Methods of catheter placement in a body vessel are well known. Currentcatheter placement techniques may result in tearing or snagging ofvessel tissue as well as patient discomfort during placement. To addresssuch trauma, catheters are often manufactured from softer and moreflexible materials. These softer and more flexible materials may requirethe use of a stiffener to aid in the placement of the catheter in thevessel.

Therefore, it would be desirable to have a catheter apparatus thatfacilitates placement within a body vessel with reduced vessel traumaand patient discomfort. It would highly desirable if the catheterapparatus and its constituent parts are easily and efficientlymanufactured and assembled.

SUMMARY OF THE INVENTION

Accordingly, a catheter apparatus is provided that facilitates placementwithin a body vessel with reduced vessel trauma and patient discomfortto overcome the disadvantages and drawbacks of the prior art. Mostdesirably, the catheter apparatus is easily and efficiently manufacturedand assembled.

In one particular embodiment, a catheter is provided, in accordance withthe principles of the present disclosure. The catheter includes a firstlumen and a second lumen. A first member is disposed for relativemovement within the first lumen and defines a cavity. A second member isdisposed for relative movement within the second lumen. The cavity ofthe first member is configured for disposal of the second member.

In an alternate embodiment, the catheter has an elongated tubular bodydefining a first lumen and a second lumen. The first member extendswithin the first lumen and is slidably movable relative thereto. Thefirst member includes a distal portion that extends beyond a distal endof the body. The distal portion of the first member defines a memberlumen. A second member extends within the second lumen and is slidablymovable relative thereto. The second member extends beyond the distalend of the body. A wire extends through the second member and the memberlumen such that the first member and the second member extend from thedistal end of the body in a configuration for passage through a bodyvessel.

In an exemplary embodiment, the distal tip of the catheter is tapered.In another exemplary embodiment, the distal tip of the catheter iscomprised of a material having a durometer greater than the durometer ofthe body of the catheter. In another exemplary embodiment, the distaltip of the catheter comprises at least one rounded edge at a surface ofthe distal tip so that the surface is smoother than it would be in theabsence of the rounded edge. In another exemplary embodiment, the firstand second members are comprised of a first tubular stylette and asecond tubular stylette, respectively, wherein the first stylette has anouter diameter substantially equivalent to the inner diameter of thefirst lumen and the second stylette has an outer diameter substantiallyequivalent to the inner diameter of the second lumen. In yet anotherexemplary embodiment, the first and second members are comprised of afirst and second tubular stylette, respectively, wherein at least one ofthe first and second stylettes has an inner diameter that is smallerthan the outer diameter of a guidewire to be inserted into the styletteand is able to expand when the guidewire is inserted into the styletteso that the inner diameter of the stylette expands to accommodate theguidewire when the guidewire is inserted into the stylette and contractswhen the guidewire is withdrawn from the stylette.

In another exemplary embodiment a hemodialysis catheter includes anelongated tubular body including a distal end and defining a firstlumen, a second lumen and a septum disposed therebetween. A firsttubular stylette extends within the first lumen and is slidably movablerelative thereto. The first stylette includes a distal portion thatextends beyond a distal end of the body. The distal portion of the firstmember defines a member lumen. A second tubular stylette extends withinthe second lumen and is slidably movable relative thereto. The secondstylette extends beyond the distal end of the body. A guidewire extendsthrough the tubular stylette and the member lumen such that the firstmember and the second member extend from the distal end of the body in atapered configuration for guiding the catheter through a body vessel.

A method for inserting a catheter within a vessel of a body is provided.The method includes the steps of; disposing a guidewire within the bodyvessel, the guidewire having a proximal end and a distal end; providinga catheter including a first lumen and a second lumen; providing a firstmember being disposed for relative movement within the first lumen anddefining a cavity, a second member being disposed for relative movementwithin the second lumen and including the guidewire; inserting theproximal end of the guidewire through the cavity of the first member;inserting the proximal end of the guidewire, passed through the cavityof the first member, into a distal end of the second member; and passingthe proximal end of the guidewire through the second member to aproximal end thereof such that a distal end of the catheter is disposedat a location within the body vessel.

In another exemplary embodiment a catheter includes a first lumen and asecond lumen. A first member is disposed for relative movement withinthe first lumen and defines a member lumen. A second member is disposedfor relative movement within the second lumen. The member lumen of thefirst member is configured for disposal of the second member.

In another exemplary embodiment a catheter includes an elongated tubularbody defining a first lumen and a second lumen. A first member extendswithin the first lumen and is slidably movable relative thereto. Thefirst member includes a distal portion that extends beyond a distal endof the body. The distal portion of the first member defines a memberlumen. A wire extends through the second lumen and the member lumen suchthat the first member extends from the distal end of the body in aconfiguration for passage through a body vessel.

In another exemplary embodiment, a hemodialysis catheter includes anelongated tubular body including a distal end and defining a firstlumen: a second lumen and a septum disposed therebetween. A firsttubular stylette extends within the first lumen and is slidably movablerelative thereto. The first stylette includes a distal portion thatextends beyond a distal end of the body. The distal portion of the firstmember defines a member lumen. A guidewire extends through the secondlumen and the member lumen such that the first member extends from thedistal end of the body in a tapered configuration for guiding thecatheter through a body vessel.

In yet another exemplary embodiment, a catheter includes an elongatedtubular body defining a first lumen, second lumen and third lumen. Afirst member extends within the first lumen and is slidably movablerelative thereto. The first lumen includes a distal portion that extendsbeyond a distal end of the body. The distal portion of the first memberdefines a member lumen. A second member extends within the second lumenand is slidably movable relative thereto. The second member extendsbeyond the distal end of the body. A wire extends within the third lumenand is slidably movable relative thereto. The wire extends through thesecond member and member lumen so that the first member and secondmember extend from the distal end of the body in a configuration forpassage through a body vessel.

BRIEF DESCRIPTION OF THE DRAWINGS

The objects and features of the present disclosure, which are believedto be novel, are set forth with particularity in the appended claims.The present disclosure, both as to its organization and manner ofoperation, together with further objectives and advantages, may foe bestunderstood by reference to the following description, taken inconnection with the accompanying drawings, as set forth below.

FIG. 1 is a cutaway perspective view of a catheter in accordance withthe principles of the present disclosure;

FIG. 2 is an enlarged cutaway perspective view of the catheter shown inFIG. 1;

FIG. 3 is an enlarged cross section view of a second member of thecatheter shown in FIG. 1;

FIG. 4 is a cutaway plan view of an alternate embodiment of a distal endof the second member shown in FIG. 1;

FIG. 5 is a cutaway perspective view of a proximal end of the cathetershown in FIG. 1;

FIG. 6 is a cutaway perspective view of a distal end of the cathetershown in FIG. 1;

FIG. 7 is a cutaway perspective view of the distal end of the cathetershown in FIG. 1;

FIG. 8 is a cutaway perspective view of the distal end of the cathetershown in FIG. 1;

FIG. 9 is a cutaway perspective view of the distal end of the cathetershown in FIG. 1;

FIG. 10 is a cutaway perspective view of an alternate embodiment of thecatheter shown in FIG. 1;

FIG. 11 is a cutaway plan view of a distal end of the catheter shown inFIG. 10;

FIG. 12 is an enlarged cutaway plan view of the distal end of thecatheter shown in FIG. 10;

FIGS. 13A and 13B are enlarged perspective views of exemplary catheters;

FIG. 14 is an enlarged perspective view of another exemplary catheter;

FIG. 15 is a cross-sectional view of an exemplary catheter and tubularstylettes; and

FIG. 16 is an enlarged perspective view of an exemplary catheter andtubular stylette.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

The exemplary embodiments of the catheter and methods of use disclosedare discussed in terms of medical catheters for the administration offluids of a subject and more particularly, in terms of a catheter thatfacilitates placement within a body vessel. The catheter isadvantageously configured to reduce trauma and prevent patientcomplications. It is envisioned that the present disclosure may beemployed with a range of catheters, such as, for example, hemodialysis,peritoneal, infusion, PICC, CVC, port, biliary, urethral, in any acuteand/or chronic catheter application.

In the discussion that follows, the term “proximal” will refer to theportion of a structure that is closer to a practitioner, while the term“distal” will refer to the portion that is further from thepractitioner. As used herein, the term “subject” refers to a humanpatent or other animal. According to the present disclosure, the term“practitioner” refers to a doctor, nurse or other care provider and mayinclude support personnel.

The following discussion includes a description of the catheter, inaccordance with the principles of the present disclosure. Reference willnow be made in detail to the exemplary embodiments of the disclosure,which are illustrated in the accompanying figures.

Turning now to the figures, wherein like components are designated bylike reference numerals throughout the several views. Referringinitially to FIGS. 1 and 2, a catheter 20 includes an elongated tubularbody 22 including a proximal end 24 (FIG. 5) and a distal end 26. Body22 defines a first lumen 28, a second lumen 30 and a septum 32 disposedtherebetween (all shown in phantom in FIG. 2). It is contemplated thatdistal end 26 may have various configurations, such as, for example,tapered and symmetrical. It is further contemplated that body 22 may bevariously dimensioned including length and diameter, such as, forexample, 13-15 French.

A first member, such as, for example, first tubular stylette 34 extendswithin first lumen 28 and is slidably movable relative thereto. It iscontemplated that first stylette 34 may have varying degrees of rigidityor stiffness. First stylette 34 includes a distal portion 36 thatextends beyond distal end 26. It is contemplated that the first membermay be tubular, solid, have a tubular portion, have a solid portion,combinations thereof and the like, etc.

Distal portion 36 defines a cavity, such as, for example, member lumen38 (shown in phantom in FIG. 2). Member lumen 38 includes a distalopening 40 and a proximal opening 42. Member lumen 38 is configured forslidable movement of a guidewire 46 therein to facilitate passage ofcatheter 20 to a desired location within a body vessel (not shown). Itis envisioned that member lumen 38 may have various configurations, suchas, for example, cylindrical, rectangular, elliptical, polygonal,combinations thereof and the like, etc. Member lumen 38 may beconfigured for movement of various structures therein, in variousdirections and orientations, according to the requirements of aparticular catheter application. It is contemplated that the cavity mayinclude a loop or hole.

A second member includes, for example, second tubular stylette 44 (shownclearly in FIGS. 6-9) which extends within second lumen 30 and isslidably movable relative thereto. Second stylette 44 has a distalportion 47 (shown clearly in FIGS. 6-9) that extends beyond distal end26. It is contemplated that second stylette 44 may have varying degreesof rigidity or stiffness. When disposed within lumens 28, 30, distalportion 36 of first stylette 34 extends beyond distal portion 47 ofsecond stylette 44 such that distal portions 36, 47 are offset. It iscontemplated that stylettes 34, 44 may be of alternative lengths.Stylettes 34, 44 are employed within body 22 to provide stiffening ofdistal end 26 and tapering of catheter 20. Stylettes 34, 44 are alsoconfigured to maintain integrity after placement. This configuration ofcatheter 20 advantageously forms a transition to facilitate placement ofcatheter 20 within a body vessel (not shown) thereby reducing trauma andpreventing patient complications. It is contemplated that the secondmember may fee tubular, solid, may have tubular portion, have a solidportion, combinations thereof and the like, etc.

The second member includes a guidewire 46 that is configured to extendthrough second stylette 44 and member lumen 38 such that first stylette34 and second stylette 44 extend from distal end 26 in a taperedconfiguration for guiding catheter 20 through a body vessel. It iscontemplated that the second member may not include guidewire 46 andthat guidewire 46 is a separate component of catheter 20. Guidewire 46is of sufficient rigidity to support body 22 during placement and mayhave a smooth outer surface. It is envisioned that guidewire 46 may havea lubricious coating. Suitable lubricious coatings include, for example,hydrophilic coating, polytetrafluoroethylene (PTFE), silicone oil, otherbiocompatible lubricant, combinations thereof and the like. Guide wire46 may be of various lengths to extend into the heart and beyond body22. Catheter 20 may also include a guidewire outer sheath (not shown),disposed for positioning within lumen 30 and over guidewire 46. Theguidewire outer sheath enhances stiffening and facilitates passage ofbody 22 through a subcutaneous tract

Second stylette 44 is elongated and has a substantially D-shaped orsemi-circular cross-section, as shown in FIG. 3. Second stylette 44defines a passage 45 configured for slidable movement of guidewire 48therein. Passage 45 may have various cross-sectional configurations,such as, for example, oval, rectangular, elliptical, polygonal,combinations thereof and the like. It is contemplated that firststylette 34 has a substantially D-shaped or semi-circular cross-section.It is further contemplated that the outer surfaces of stylettes 34, 44may have various cross-sectional configurations, such as, for example,oval, rectangular, elliptical, polygonal, combinations thereof and thelike. The outer surfaces of stylettes 34, 44 may conform to the innersurfaces of lumens 28, 30 to advantageously decrease friction andfacilitate transition during placement of distal end 26. Stylettes 34,44 may or may not be of uniform configuration with the inner surface oflumens 28, 30. In an alternate embodiment, as shown in FIG. 4, distalportion 47 of second stylette 44 has an angled tip 147 to provide atransition with first stylette 34. It is contemplated that tip 147 maybe received by proximal opening 42 of member lumen 38.

Distal end 26 of body 22 includes a septum extension 48 that extendsdistally beyond first lumen 28 and second lumen 30. Septum extension 48extends to prevent occlusion of first lumen 28 and second lumen 30during use. It is envisioned that distal end 26 may not include anextension, and alternatively lumens 28, 30 may be in longitudinalalignment or staggered, it is further envisioned that lumens 28, 30,adjacent distal end 26, may include a spiral configuration.

Body 22 has a cylindrical outer surface 50. It is contemplated that body22 may be variously dimensioned and attachable to other medical devices.It is further contemplated that outer surface 50 may have variouscross-sectional configurations, such as, for example, oval, rectangular,elliptical, polygonal, combinations thereof and the like. Body 22 mayalso include lateral openings.

Lumens 28, 30 each have a substantially D-shaped or semi-circularcross-section. Lumens 28, 30 are elongated with body 22 and areconfigured to facilitate fluid flow. It is contemplated that lumens28,30 may be configured for arterial and/or venous flow. It isenvisioned that lumens 28, 30 may have various configurations, such as,for example, cylindrical, rectangular, elliptical, polygonal,combinations thereof and the like. Lumens 28, 30 may toe-configured forvarious forms of fluid flow in various directions and orientations,according to the requirements of a particular catheter application.

Lumens 28, 30 may be uniformly dimensioned or include alternativedimensional cross sections within body 22, such as, narrow and broadportions, converging surfaces, undulating surfaces, combinations thereofand the like, etc. according to the particular flow indications and/orflow rate requirements. It is contemplated lumen 28 and lumen 30 mayextend alternative lengths. It is further contemplated that body 22 mayinclude one or a plurality of lumens, such as, for example, a triplelumen configuration, similar to that discussed below with regard toFIGS. 10-12.

First lumen 28 includes an inlet opening 62 that is disposed adjacent todistal end 26 of body 22. An outlet opening 54 (FIG. 5) of first lumen28 is disposed adjacent a proximal end 24 of body 22. Inlet opening 52may be variously dimensioned and configured, such as, for example,rectangular, elliptical, polygonal, combinations thereof and the like,and may include adapters, clips, etc. to facilitate fluid flow and/orattachment to other structure. Second lumen 30 includes an outletopening 56 (shown in phantom in FIG. 2) that is disposed adjacent todistal end 26. An inlet opening 58 (FIG. 5) of second lumen 30 isdisposed adjacent proximal end 24. Outlet opening 56 may foe variouslydimensioned and configured, such as, for example, rectangular,elliptical, polygonal, combinations thereof and the like, etc. and mayinclude adapters, clips, etc. to facilitate fluid flow and/or attachmentto other structure.

The components of catheter 20 are fabricated from materials suitable formedical applications, such as, for example, polymerics or metals, suchas stainless steel, combinations thereof and the like depending on theparticular catheter application and/or preference of a practitioner.Semi-rigid and rigid polymerics such as, for example, polyvinylchloride(PVC) and polycarbonate (PC) are contemplated for fabrication, as wellas resilient materials, such as molded medical-grade polypropylene,thermoplastic urethanes, or polyethylene. For example, stylettes 34, 44may be made from polytetrafluoroethylene, polyethylene, other materialshaving similar durometer range and low friction properties, combinationsthereof and the like. Stylettes 34, 44 can be compatible with a standarduncoated coil guidewire for cost efficiency, as well as other coatedguidewires and coils. Stylettes 34, 44 may include a hydrophiliccoating, polytetrafluoroethylene (PTFE), silicone oil or otherbiocompatible lubricant, combinations thereof and the like on part orall of the components to enhance insertion in catheter 20, tissue and abody lumen, as well as removal after catheter placement. Proximal end 24of catheter 20 may have a luer adapter or threaded adapter. Catheter 20may be color coded to match various components. Alternatively, a valveadapter (not shown) is attachable to proximal end 24. The valve adaptermay be integral with catheter 20. Proximal end may include structurethat allows guidewire 46 to be fixed in position relative to stylette44, such as, for example, a pinch clamp or Tuohy-borst adapter, toprevent guidewire 46 from unintentionally moving in or out of the vesselduring insertion. One skilled in the art, however, will realize thatother materials and fabrication methods suitable for assembly andmanufacture, in accordance with the present disclosure, also would beappropriate.

The components of catheter 20, as shown in FIGS. 5-9, similar to thatdescribed, are assembled, sterilized and packaged for use. In operation,catheter 20 is prepared for disposal within a body vessel (not shown) incontemplation of a hemodialysis for a subject. Initially, a hollowneedle cannula (not shown) is inserted into the body vessel. It iscontemplated that the needle cannula creates a venotomy or entry sitewithin the subject for body vessel access. The needle cannula may bedisposed within the skin of the subject, adjacent the neck and clavicle,for accessing a vein. Guidewire 46 is inserted through a proximal end ofthe needle cannula and tunneled through to a desired location within thebody vessel. The needle cannula is removed leaving guidewire 46 disposedwithin the body vessel and having a proximal end of guidewire 46extending from the body vessel to the exterior of the subject. It isenvisioned that in particular applications the skin may be nicked oneither side of guidewire 46 with a scalpel (not shown) so that asubcutaneous vessel entry site can be pre-dilated. It is furtherenvisioned that a dilator may be fed with guidewire 46 into a venotomysite to pre-dilate the entry site.

A tunneler (not shown) is attached to distal end 26 and inserted throughan exit site in contemplation of forming a subcutaneous tract. Itisenvisioned that the exit site may be disposed adjacent to the chest wallbelow a venotomy site. The tunneler tunnels a subcutaneous tract fromthe exit site to the venotomy site. The tunneler is attached to distalend 26 such that the tunneler draws distal end 26 through thesubcutaneous tract to the venotomy site. Body 22 is pulled through thevenotomy site. The tunneler is removed from distal end 26. It isenvisioned that the tunneler may include a sheath to enclose the matingconnection with distal end 26. The sheath may also prevent trauma to thesubject during passage through the subcutaneous tract.

Stylettes 34, 44 are assembled with lumens 28, 30, via insertion withopenings 54, 58, respectively and shown in FIG. 5. Stylettes 34, 44 areadvanced distally through lumens 28, 30 and extend distally beyonddistal end 26 of body 22, as shown in FIG. 6. It is anticipated thatstylettes 34, 44 may be threaded onto adapters 100, as shown in FIG. 5.Distal portion 36 of first stylette 34 extends beyond distal portion 47of second stylette 44. First stylette 34 is longer than second stylette44. It is envisioned that first stylette 34 and second stylette 44 maybe inserted in lumens 28, 30, respectively, prior to insertion ofstylettes 34, 44 within the vessel or assembled after insertion, by thepractitioner.

The proximal end of guidewire 46, disposed within the body vessel, isreceived by distal opening 40 of member lumen 38, as shown in FIG. 7.First stylette 34 is manipulated distally such that the proximal end ofguidewire 46 exits proximal opening 42 of member lumen 38. The proximalend of guidewire 46 is manipulated for insertion with distal portion 47of second stylette 44, as shown in FIG. 8. Guidewire 46 is continuouslyfed through member lumen 38 and passage 45 of second stylette 44 suchthat stylettes 34, 44 are placed distally within the body vessel to adesired location (not shown). Stylettes 34, 44 are continuously fedthrough lumens 28, 30 of catheter 20 such that lumens 28, 30 are placeddistally within the body vessel to a desired location. Guidewire 46 andstylettes 34, 44 may be removed from the body vessel and catheter 20.Catheter 20 may be maintained in position. Lumens 28, 30 may be flushedwith fluid.

Guidewire 46 extends through second stylette 44 and member lumen 38 suchthat first stylette 34 and second stylette 44 extend from distal end 26of body 22 in a tapered configuration for guiding catheter 20 throughthe body vessel. The above-described procedure for disposal of catheter20 within a body vessel may be used for Seldinger procedures, tunneling,reverse tunneling, and other related procedures. It is contemplated thatprior to insertion of guidewire 46 into first stylette 34, catheter 20may be tunneled through subcutaneous skin to a position on the chest orneck of the subject, according to the requirements of a particularapplication.

Upon placement of catheter 20 at a desired location within a bodyvessel, it is envisioned that catheter 20 may be employed foradministration of fluids within the body of a subject in proceduresalternate to hemodialysis. Catheter 20 and other exemplary cathetersdescribed herein may be employed for: double-lumen catheter exchangeover a single wire; direct placement of a catheter through a tunnel;dialysis catheters, tunneled and acute non-tunneled; chronic tunneledinfusion catheters, such as Hickman catheters; acute infusion catheters,such as triple lumen central venous catheters; and various multi-lumencatheters.

Operation of catheter 20 and other exemplary catheters described hereinmay benefit from several advantages including; efficiency, instead ofusing two wires for tunneled dialysis catheter exchange, catheter 20 maybe used over a single wire; safety, catheter 20 reduces trauma to thevenotomy by providing a smooth tapering to the catheter tip and isocclusive to reduce the likelihood of air embolization through thelumens; and patient comfort and safety, catheters 20 may be composedfrom softer materials that are more comfortable to the patient and lesstraumatic. Catheter 20 eliminates the use of a peel away catheter alongwith the associated risk of air embolization. Further, catheter 20 iscost-effective by eliminating the need for a second guidewire andpeel-away structure, as well as reducing the time required for aprocedure. Catheter 20 can also reduce the need for multiple dilatation,making the procedure easier and faster.

Referring to FIGS. 10-12, in an alternate embodiment, catheter 20,similar to that described with regard to FIGS. 1-9, has a triple lumenconfiguration. Body 22 defines a first lumen 228, a second lumen 230(similar to lumens 28, 30 described above) and a third lumen 231 (thephantom lead line portions identifying the inner lumen). A septum 232 isdisposed between first lumen 228 and second lumen 230, and is connectedto the portion of body 22 that defines third lumen 231.

A first tubular stylette 234 extends with first lumen 228 and isslidably movable relative thereto. First stylette 234 includes a distalportion 236 that extends beyond distal end 26. Distal portion 236defines a member lumen 238 that includes a distal opening 240 and aproximal opening 242. Member lumen 238 is configured for slidablemovement of a guidewire 246 therein to facilitate passage of catheter 20to a desired location within a body vessel (not shown).

Guidewire 246 extends with third lumen 231 and is slidably movablerelative thereto. Guidewire 246 may be fixed within third lumen 231.Lumen 231 has a substantially circular cross-section, however, may beD-shaped or semi-circular depending on the requirements of a particularapplication. It is envisioned that lumen 231 may have variousconfigurations, such as, for example, cylindrical, rectangular,elliptical, polygonal, combinations thereof and the like. Guidewire 246may be configured to extend with any of the lumens of body 22.

Lumen 231 may be uniformly dimensioned or include alternativedimensional cross sections within body 22, such as, narrow and broadportions, converging surfaces, undulating surfaces, combinations thereofand the like, etc. Lumen 231 includes an inlet opening 252 disposedadjacent to distal end 26 of body 22. An outlet opening (not shown) oflumen 231 is disposed adjacent a proximal end 24 of body 22.

A second tubular stylette 244 extends within second lumen 230 and isslidably movable relative thereto. Second stylette 244 has a distalportion 247 that extends beyond distal end 26. Distal portion 247defines a member lumen 248 that includes a distal opening 249 and aproximal opening 250. Member lumen 248 is configured for slidablemovement of guidewire 246 therein to facilitate passage of catheter 20to a desired location within a body vessel. When disposed within lumens228, 230, distal portion 236 of first stylette 234 extends beyond distalportion 247 of second stylette 244 such that distal portions 236, 247are offset. Stylettes 234, 244 are employed with body 22 to providestiffening of distal end 26 and tapering of catheter 20. Thisconfiguration of catheter 20 advantageously forms a transition tofacilitate placement of catheter 20 within a body vessel (not shown)thereby reducing trauma and preventing patient complications.

Guidewire 246 is configured to extend through member lumens 238,248 suchthat first stylette 234 and second stylette 244 extend from body vessel.Stylettes 234, 244 are assembled with lumens 228, 230 and advanceddistally to extend beyond distal end 26 of body 22. Distal portion 236of first stylette 234 extends beyond distal portion 247 of secondstylette 244.

The proximal end of guidewire 246 is received by distal opening 240 ofmember lumen 238. First stylette 234 is manipulated distally such thatthe proximal end of guidewire 246 exits proximal opening 242 of memberlumen 238. The proximal end of guidewire 246 is manipulated forinsertion with distal portion 247 of second stylette 244. Distal opening249 receives guidewire 246. Second stylette 244 is manipulated distallysuch that the proximal end of guidewire 246 exits proximal opening 250.Guidewire 246 is fed through member lumens 238, 248 into third lumen231. Guidewire 246 is continuously fed through member lumens 238, 248and third lumen 231 such that stylettes 234, 244 may be placed distallywithin the body vessel to a desired location.

Guidewire 246 extends through member lumens 238, 248 and third lumen 231such that first stylette 234 and second stylette 244 extend from distalend 26 of body 22 in a tapered configuration for guiding catheter 20through the body vessel. Catheter 20 may be used for Seldingerprocedures, tunneling, reverse tunneling, and other related procedures.This configuration advantageously decreases vessel trauma and may reduceair embolism.

In exemplary embodiments, a catheter can include a tapered distal tip toprovide enhanced tracking and/or insertion of the catheter into tissuetracks and/or body vessels. To provide a tapered tip, thecross-sectional area of the distal tip region of the catheter may bereduced. The reduction in cross-sectional area may also decrease thesize of the catheter lumens. In order to avoid any unacceptablereduction of flow that may result, the tapered distal tip cars includeat least one of a spiral cut opening and slots. Tapering of the distaltip can be achieved by re-forming the distal tip of the catheter and/orthe addition of a tapered tip structure and secure bonding, heatsealing, and/or welding of the tip structure to the catheter body using,for example, one or more suitable adhesives such as, for example,adhesives selected from the group consisting of a silicone adhesive, acyanoacrylate adhesive, an acrylic adhesive, and epoxy adhesive, apolyurethane adhesive, combinations thereof and the like Re-forming ofthe catheter tip can be achieved using any suitable method including,for example, a heat re-forming method, a mechanical re-forming method, achemical re-forming method, combinations thereof, and the like. Anexemplary tapered catheter 300 is depicted in FIG. 13A. The catheter 300includes a slot 301 in the catheter body 302 and a tapered distal tip303. The catheter 300 in FIG. 13A also includes a spiral out opening 304to facilitate fluid flow through the lumen 299. Thus, when compared to anon-tapered catheter such as catheter 305 depicted in FIG. 13B having ablunt tip 308, the catheter 300 may have a reduced cross-sectional areaat the distal tip region due to the tapered configuration of tip 303.The catheter 300 having the tapered tip 303 may, however, providesuperior tracking and/or Insertion of the catheter 300 into tissuetracks and/or body vessels compared to the blunt-tipped catheter 305.

Tapering of the distal tip, in addition to providing an improved profilefor insertion and passage through tissue may allow for a closer fit onstylettes, or a guidewire, used for tracking and reinforcement of thecatheter.

The catheter 300 in FIG. 13A also includes a spiral out 304 having aspiral pitch that is greater than the pitch of spiral cut 309 ofcatheter 305 depicted in FIG. 13B. Because the pitch of cut 304 isgreater than the pitch of cut 309 of catheter 305, insertion of catheter300 may be further enhanced compared to catheter 305.

Enhanced insertion may also be achieved by providing a distal tip regioncomprised of a material having a durometer greater than the durometer ofthe catheter body. For example, while the catheter body 302 or 307 mayremain fairly flexible having a lower respective durometer, the tipregion of the catheter 300 or 305 can be harder and less flexiblethereby enhancing insertion and passage of the distal tip 303 or 308through tissue.

Another exemplary embodiment of a catheter 315 is depicted in FIG. 14.Catheter 315 includes a slot 316 in the catheter body 317 and spiral outopening 318. The catheter 315 also includes a longitudinally extendingseptum 319. To enhance insertion of the catheter 315, the catheter 315further includes fillets or rounded edges 320 and 321 at the distal endof the catheter proximal to the spiral cut opening 318 and the septum319. The rounded edges 320 and 321 substantially reduce or eliminatesharp edges at the distal end of the catheter 315 thereby creatingsurfaces that are smoother than they would have been in the absence ofthe rounded edges 320 and 321. The rounded edges 320 and 321 maysignificantly improve insertion of the catheter 315 by reducing drag.Although the catheter depicted in FIG. 14 includes two rounded edges,exemplary embodiments can include one more fillets and/or rounded edgesat any location on the catheter where a fillet or rounded edge mayreduce drag to improve insertion.

Another exemplary embodiment is depicted in FIG. 15. Catheter 325includes first and second stylettes for insertion and relative movementwith respect to a first and second lumen in the catheter 325. Thestylettes 326, 327 may be provided with an outer diameter 330, 331 thatis substantially equivalent to the inner diameter 332, 333 of the lumens328, 329. By providing stylettes 326, 327 with outer diameters 330, 331that are substantially equivalent to the inner diameter 332, 333 of thelumens 328, 329, the ability to advance the catheter 325 may be enhancedby substantially reducing space between the exterior surface of thestylettes 326, 327 and the interior surface of the lumens 328, 329,which may otherwise catch the distal tip of a catheter on tissue. Inaddition, by increasing the size of the stylettes, stiffness of thecatheter may also be increased. Catheter stiffness may also be improvedby increasing the wall thickness of the stylettes.

Another exemplary embodiment of a catheter 335 is depicted in FIG. 18.Catheter 335 includes a catheter body 338 and a spiral cut 337 at adistal lumen opening 338. A stylette 339 having a normal inner diameter342 is inserted into the distal lumen opening 338. The tubular stylette339 is configured so that sis normal inner diameter 342 is smaller thanthe outer diameter 344 of a guidewire 341 to be inserted into thetubular stylette 339. The tubular stylette 339 is configured to expandso that its normal, inner diameter 342 expands to accommodate theguidewire 341 when the guidewire is inserted into the stylette 339 andcontracts when the guidewire 341 is withdrawn from the tubular stylette339. In an exemplary embodiment, the tubular stylette 339 can include aslit 340 in the body of the tubular stylette 339 to permit the desiredexpansion and contraction during insertion and withdrawal of theguidewire 341. Alternatively, it is possible that the tubular stylette339 could be made of a flexible material or otherwise configured topermit expansion and contraction during insertion and withdrawal of theguidewire 341, instead of or in addition to silt 340. In addition, whilestylette 339 depicted in FIG. 16 includes a single slit 340, exemplaryembodiments may include 2, 3, 4 or more slits to achieve the desiredexpansion and contraction. In its expanded state, the inner diameter ofthe stylette 339 may increase to an expanded inner diameter 343 toaccommodate the outer diameter 344 of the guidewire 341. When theguidewire 341 is inserted into the tubular stylette 339 and the innerdiameter 342 is expanded as depicted, insertion of the catheter 335 isenhanced because the tubular stylette 339 acts as a dilator for thedistal tip of the catheter. Expansion of the stylette can also beachieved using an assembly wherein the stylette and guidewire areintegral and move relative to one another to expand and contract thestylette. Expansion of the stylette may also be achieved by increasingthe outer diameter of the guidewire instead of providing a stylettehaving an expandable, inner diameter. Expansion of the stylette may alsobe achieved using a balloon inflated with a fluid such as, for example,air or water, when the lumen needs to be occluded prior to insertion.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A catheter comprising: an elongated body defininga first lumen, a second lumen, and a septum disposed between the firstand second lumens; a first member defining a cavity, the first memberextending within the first lumen and being slidably movable relative tothe first lumen; and a second member received within the second lumenand configured to be slidably movable relative to the second lumen,wherein the cavity of the first member is configured to receive thesecond member, wherein when the second member is within the cavity ofthe first member, the first and second members are configured to extendbeyond a distal end of the elongated body in a tapered configuration. 2.The catheter of claim 1, wherein the first member comprises a distalportion that extends beyond the distal end of the elongated body, andwherein the distal portion defines the cavity.
 3. The catheter of claim1, wherein the first member defines a member lumen, the cavity being aportion of the member lumen.
 4. The catheter of claim 1, wherein thesecond member includes a stylette.
 5. The catheter of claim 1, whereinthe second member includes a guidewire.
 6. The catheter of claim 1,wherein the second member includes a stylette and a guidewire configuredto extend through the stylette and the cavity.
 7. The catheter of claim6, wherein the first member includes a distal portion that extendsbeyond the distal end of the elongated body, the distal portionextending beyond a distal end of the stylette when the guidewire extendsthrough the stylette and the cavity.
 8. The catheter of claim 7, whereinthe distal tip defines at least one rounded edge.
 9. The catheter ofclaim 1, wherein at least a portion of at least one of the first memberor the second member has a greater rigidity relative to the elongatedbody.
 10. The catheter of claim 1, wherein a distal tip of the elongatedbody is comprised of a material having a durometer greater than adurometer of a more proximal portion of the elongated body.
 11. Thecatheter of claim 1, wherein the first and second members comprise afirst stylette and a second stylette, respectively, and wherein thefirst stylette has an outer diameter substantially equivalent to aninner diameter of the first lumen and the second stylette has an outerdiameter substantially equivalent to an inner diameter of the secondlumen.
 12. The catheter of claim 1, wherein the cavity defined by thefirst member is a member lumen, the first member defining first andsecond openings in communication with the member lumen, the secondmember being insertable, from distal to proximal, into the first openingof the first member, through the member lumen, and out of the secondopening of the first member, and into the second lumen of the elongatedbody.
 13. The catheter of claim 12, wherein at least one of the firstopening or the second opening is a slit defined by the elongated body.14. The catheter of claim 1, further comprising a guidewire, wherein thefirst and second members comprise a first stylette and a secondstylette, respectively, and wherein at least one of the first styletteor the second stylette has an inner diameter that is smaller than anouter diameter of the guidewire, and wherein when the guidewire isinserted into the at least one of the first stylette or the secondstylette, the inner diameter of the at least one of the first styletteor the second stylette expands to accommodate the guidewire and when theguidewire is withdrawn from the at least one of the first stylette orthe second stylette, the inner diameter contracts.
 15. The catheter ofclaim 1, wherein the elongated body defines a third lumen configured toreceive a guidewire.
 16. The catheter of claim 1, wherein the elongatedbody defines a septum extension extending distally beyond the first andsecond lumens.
 17. A catheter comprising: a catheter body defining afirst lumen, a second lumen, and a septum between the first and secondlumens; a stylette extending within the first lumen and being slidablymovable relative thereto, the stylette including a distal portionconfigured to extend beyond a distal end of the catheter body, thedistal portion of the stylette defining a member lumen; and an elongatedmember extending through the second lumen and the member lumen such thatthe stylette and the elongated member extend beyond the distal end ofthe catheter body in a tapered configuration.
 18. The catheter of claim17, wherein the elongated member comprises a guidewire.
 19. The catheterof claim 17, wherein the catheter body defines a septum extensionextending distally beyond the first and second lumens.
 20. The catheterof claim 17, wherein a distal tip of the catheter body is comprised of amaterial having a durometer greater than a durometer of a more proximalportion of the catheter body.
 21. The catheter of claim 17, wherein thestylette comprises a first stylette, the catheter further comprising asecond stylette, wherein at least one of the first stylette or thesecond stylette has an inner diameter that is smaller than an outerdiameter of the elongated member, and wherein when the elongated memberis inserted into the at least one of the first stylette or the secondstylette, the inner diameter of the at least one of the first styletteor the second stylette expands to accommodate the elongated member andwhen the elongated member is withdrawn from the stylette, the innerdiameter contracts.
 22. A method comprising: introducing a catheter intoa patient, the catheter comprising: an elongated body defining a firstlumen, a second lumen, and a septum disposed between the first andsecond lumens; a first member defining a cavity, the first memberextending within the first lumen and being slidably movable relative tothe first lumen; and a second member received within the second lumenand configured to be slidably movable relative to the second lumen,wherein the cavity of the first member is configured to receive thesecond member, wherein when the second member is within the cavity ofthe first member, the first and second members are configured to extendbeyond a distal end of the elongated body in a tapered configuration;guiding the catheter to a target site within the patient; and after thecatheter is guided to the target site, removing the second member fromthe cavity of the first member.
 23. The method of claim 22, wherein thesecond member includes a stylette.
 24. The method of claim 22, whereinthe second member includes a guidewire.